Kornimate/medical-research-clean huggingface dataset:
detection of amyloidosis in multiple myeloma patients by [18f]florbetaben positron emission tomography

Conditions: Multiple Myeloma

Summary: \[18f\]florbetaben pet/ct imaging will noninvasively assess amyloid deposition in systemic amyloidosis.

diagnostic validity of \[18f\]florbetaben pet for detecting amyloidosis will be assessed in subjects with multiple myeloma.

Eligibility criteria:
inclusion criteria: * subject is over 19 years old and male or female of any race/ethnicity * subject has been diagnosed with multiple myeloma by a hemato-oncology specialist * subject has undergone clinical, laboratory, or imaging work-up if amyloidosis is suspected * subject has voluntarily agreed to participate in the study exclusion criteria: * subject or subject's legally acceptable representative does not provide written informed consent. * female subject is pregnant or nursing. exclusion of the possibility of pregnancy is made by one of the following: 1) woman is physiologically post-menopausal (cessation of menses for more than 2 years), 2) woman is surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy, or 3) if the woman is of childbearing potential, a serum or urine pregnancy test performed within 24 hours immediately prior to administration of \[18f\]florbetaben has to be negative and the women is advised to apply contraceptive measures during her participation in this study. * subject has concurrent severe and/or uncontrolled and/or unstable medical disease (which could compromise participation in the study) in the judgment of the investigator. * subject has received any investigational drugs or devices within four weeks prior to the study enrollment. * subject has been previously included in this study. * subject has any other condition or personal circumstances that, in the judgment of the investigator, might make collection of complete data difficult or impossible. * subject is allergic to florbetaben or any of ingredients of florbetaben

Keywords: multiple myeloma amyloidosis florbetaben
prolonged or standard infusion of cefepime hydrochloride in treating patients with febrile neutropenia

Conditions: Adult Acute Lymphoblastic Leukemia; Adult Acute Myeloid Leukemia; Adult Burkitt Lymphoma; Adult Diffuse Large Cell Lymphoma; Adult Diffuse Mixed Cell Lymphoma; Adult Diffuse Small Cleaved Cell Lymphoma; Adult Hodgkin Lymphoma; Adult Immunoblastic Large Cell Lymphoma; Adult Lymphoblastic Lymphoma; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Breast Cancer; Chronic Eosinophilic Leukemia; Chronic Lymphocytic Leukemia; Chronic Myelogenous Leukemia; Chronic Myelomonocytic Leukemia; Chronic Neutrophilic Leukemia; Cutaneous T-cell Non-Hodgkin Lymphoma; Disseminated Neuroblastoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Grade 1 Follicular Lymphoma; Grade 2 Follicular Lymphoma; Grade 3 Follicular Lymphoma; Malignant Testicular Germ Cell Tumor; Mantle Cell Lymphoma; Marginal Zone Lymphoma; Multiple Myeloma; Mycosis Fungoides/Sezary Syndrome; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Neutropenia; Nodal Marginal Zone B-cell Lymphoma; Ovarian Epithelial Cancer; Ovarian Germ Cell Tumor; Plasma Cell Neoplasm; Poor Prognosis Metastatic Gestational Trophoblastic Tumor; Primary Myelofibrosis; Prolymphocytic Leukemia; Small Lymphocytic Lymphoma; Splenic Marginal Zone Lymphoma

Summary: this randomized pilot clinical trial studies how well giving prolonged infusion compared to standard infusion of cefepime hydrochloride works in treating patients with febrile neutropenia. giving cefepime hydrochloride over a longer period of time may be more effective than giving cefepime hydrochloride over the standard time.

objectives: i. the objective of this study is to describe outcomes associated with prolonged infusion (3 hours) compared to standard infusion (30 minutes) cefepime (cefepime hydrochloride) among patients being treated empirically for febrile neutropenia. outline: patients are randomized 1 of 2 treatment arms. all patients receive cefepime hydrochloride intravenously (iv) over 30 minutes as their first dose. arm i: patients receive cefepime hydrochloride intravenously (iv) over 30 minutes. arm ii: patients receive cefepime hydrochloride iv over 3 hours. treatment repeats every 8 hours.

Eligibility criteria:
inclusion criteria: * absolute neutrophil count \< 500 cells/mm\^3 or \< 1000 cells/mm\^3 with a predicted decrease to \< 500 cells/mm\^3 * temperature \> 38.0 degrees celsius * received chemotherapy or stem-cell transplant as treatment for malignancy or myelodysplastic syndrome (mds) * cefepime prescribed at a dose of 2 grams iv every 8 hours exclusion criteria: * allergy to a cephalosporin antibiotic * estimated creatinine clearance \< 50 milliliters/minute * concurrent anti-gram negative antimicrobials * diagnostic criteria suggestive of sepsis * circumstances which may make 3 hour infusion impractical * solid tumor malignancy
cladribine in combination with cag in patients with refractory/relapsed acute myeloid leukemia

Conditions: Acute Myeloid Leukemia; Relapse Leukemia

Summary: the vast majority of patients with aml will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory aml. previous studies have confirmed the efficacy of cladribine in the treatment of aml, both de novo or relapse/refractory aml. our previous experience has shown that cladribine in combination of cag (g-csf priming, low dose cytarabine, and aclarubicin) are effective with tolerable toxicity profiling.thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with g-csf, low-dose cytarabine and aclarubicin (c-cag) in patients with refractory/relapsed acute myeloid leukemia.

aml is most common in the elderly patients, who can not tolerate the intensified treatments. the vast majority of patients with aml will die of the disease, and no standard chemotherapy regimen were defined for patients with relapsed/refractory aml. previous studies have confirmed the efficacy of cladribine in the treatment of aml, both de novo or relapse/refractory aml. our previous experience has shown that cladribine in combination of cag (g-csf priming, low dose cytarabine, and aclarubicin) are effective with tolerable toxicity profiling.thus, this phase 2 clincial trial is going to evaluate the efficacy and safety of cladribine in combination with g-csf, low-dose cytarabine and aclarubicin (c-cag) in patients with refractory/relapsed acute myeloid leukemia.

Eligibility criteria:
inclusion criteria: * men and women; * clinical diagnosis of relapsed/refractory aml (non-apl); * ecog performance status (ps) score 0-3; * ast and alt \<=2.5 times the institutional uln; * total bilirubin \<=2.0 times the institutional uln * serum creatinine\<2.0 times the institutional uln; * subjects should take effective contraceptive measures，and serum or urine pregnancy tests must be negative during the screening and study periods in women subjects; * patients should understand the disease and voluntarily receive the study regimen and follow-up. exclusion criteria: * concurrent diagnosis of tumors other than aml, with exclusion of superficial bladder cancer, basal cell and squamous cell carcinoma, cervical intraepithelial neoplasms (cin), prostatic intraepithelial neoplasms(pin); * active viral or bacterial infection that would impair the ability of the subject to receive protocol therapy; * concurrent autoimmune hemolytic anemia or immune thrombocytopenia; * subjects suffered from aids，active hepatitis b or c virus infection; 垫·dementia or altered mental status that would prohibit the understanding or rendering of informed consent; * be allergic to any component of c-cag regimen; * subjects ever exposed to cladribine or cag-based regimen.

Keywords: cladribine acute myeloid leukemia
red-hf™ trial - reduction of events with darbepoetin alfa in heart failure trial

Conditions: Heart Failure; Anemia; Cardiovascular Disease; Ventricular Dysfunction; Congestive Heart Failure

Summary: the purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in patients with symptomatic left ventricular systolic dysfunction and anemia.

several epidemiological studies have demonstrated an association between hf and anemia and correlation of increased risk for mortality and hospitalization with low hemoglobin in patients with hf. earlier single-center interventional studies suggest that meaningful clinical benefits may be achieved by raising hemoglobin concentration in patients with symptomatic hf and anemia. data from amgen's completed phase 2 multi-center studies support this hypothesis and show that darbepoetin alfa is well tolerated in patients with symptomatic left ventricular systolic dysfunction and anemia and effectively raises hemoglobin. the pivotal phase 3 study 20050222 red-hf trial is evaluating the effect of treatment with darbepoetin alfa on the composite risk of all-cause mortality or hospitalization for worsening hf in patients with symptomatic left ventricular systolic dysfunction and anemia. this study also evaluates the effect of darbepoetin alfa treatment on all-cause death, on cardiovascular death or hospitalization for worsening hf, and on patient-reported quality-of-life outcomes.

Eligibility criteria:
inclusion criteria: * heart failure of at least 3 months duration and of new york heart association (nyha) class ii, iii, or iv * hemoglobin between 9.0 g/dl and 12.0 g/dl * left ventricular ejection fraction equal to or less than 40% exclusion criteria: * transferrin saturation (tsat) \< 15% * blood pressure \> 160/100 mm hg * heart failure primarily due to valvular heart disease or clinically significant valvular heart disease that might lead to surgical correction within 12 months of randomization * recipient of a major organ transplant or receiving renal replacement therapy * serum creatinine \> 3.0 mg/dl (\> 265 µmol/l)

Keywords: survival study morbidity and mortality heart failure hospitalization all-cause death patient-reported outcomes kansas city cardiomyopathy questionnaire anemia treatment
androgen therapy for management of estrogen/progesterone receptor negative er(-)pr(-) metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: this study is for patients with breast cancer that has spread to other tissues and organs. the purpose of this study is to identify patients who may respond favorably to certain types of hormonal therapy. researchers will study your tumor, which was removed during your breast surgery. they will look for the presence or absence of androgen (ar) receptors. these tests are for research purposes only. they will not affect the treatment of your breast cancer. the presence or absence of androgen receptors on the tumor does not alter the therapy that is offered to patients. recent evidence suggests that ar+ tumors are more likely to be destroyed when treated with androgen drugs. we will ask about 35 er-/pr- breast cancer patients from legacy health system to be in this study. all tests and procedures are done as an outpatient in the doctor's office, a clinic, or at the hospital. the study drug that will be used in this trial is androxy®, a synthetic androgen hormone. androgens have been shown to inhibit the growth of some breast cancer cells. arimidex is an aromatase inhibitor that will be used in conjunction with androxy to inhibit the in vivo production of estrogen. it is hoped that the combination of these two drugs will inhibit the growth of your tumor and possibly cause it to shrink.


Eligibility criteria:
inclusion criteria: * over 18 years of age * er negative and pr negative * progression of disease in the metastatic setting despite taxane or other chemotherapeutic therapies including herceptin (patients on herceptin may continue this therapy while on study) * maximized chemotherapy in the metastatic setting or patient experienced side effects contributing to decreased quality of life and elects to defer chemotherapy * evaluable disease by either: * ct scan with or without contrast (lesions must be greater than 2 mm) * pet scan, or bone scan, or plain skeletal films * chest wall or skin recurrence (digital photo to capture evaluable disease) * evaluable symptoms (pain, shortness of breath, fatigue, anorexia) * performance status of 0, 1, or 2 * bilateral mammogram performed within one year before registration exclusion criteria: * uncontrolled hypercalcemia greater than 11 * uncontrolled congestive heart failure greater than 2 nyha class * central nervous system metastasis * concomitant steroid use * performance status of greater than 2 * bilirubin greater than 5.5

Keywords: er (-) and pr (-)
estimation of coagulation factor xiii activity based on the initial plasma fibrinogen level in trauma

Conditions: Multiple Trauma; Coagulation Disorder; Coagulation Factor Deficiency; Coagulation Defect; Acquired

Summary: coagulation factor xiii (fxiii), a plasma transglutaminase, is known as the final enzyme of the coagulation cascade, responsible for a cross-linking of fibrin to strengthen blood clot. it also minimizes fibrin degradation by its cross-linking it with alfa2-antiplasmin molecules. it has been found that similar to plasma fibrinogen level, fxiii activity can be reduced in the early phase of severe trauma. therefore, its immediate substitution is of potential therapeutic interest in trauma-induced coagulopathy. however, unlike plasma fibrinogen level evaluation, measurement of the fxiii activity is not routinely available. therefore, targeted substitution of fxiii is practically impossible. the plasma fibrinogen level is routinely measured in severe trauma patients. based on pathophysiologic assumptions and a limited number of published data we hypothesize that the fxiii activity correlates with fibrinogen level. in such case, indirect fxiii activity prediction by fibrinogen level measurement would be a convenient approach to enable fxiii targeted substitution. therefore we decided to perform a prospective observational clinical trial to determine whether the low plasma fibrinogen level in severe trauma correlates with decreased fxiii activity.

coagulation factor xiii (fxiii), a plasma transglutaminase, is known as the final enzyme of the coagulation cascade, responsible for a cross-linking of fibrin to strengthen blood clot. it also minimizes fibrin degradation by its cross-linking it with alfa2-antiplasmin molecules. it has been found that similar to plasma fibrinogen level, fxiii activity can be reduced in the early phase of severe trauma. therefore, its immediate substitution is of potential therapeutic interest in trauma-induced coagulopathy. however, unlike plasma fibrinogen level evaluation, measurement of the fxiii activity is not routinely available. therefore, targeted substitution of fxiii is practically impossible. the plasma fibrinogen level is routinely measured in severe trauma patients. based on pathophysiologic assumptions and a limited number of published data we hypothesize that the fxiii activity correlates with fibrinogen level. in such case, indirect fxiii activity prediction by fibrinogen level measurement would be a convenient approach to enable fxiii targeted substitution. therefore we decided to perform a prospective observational clinical trial to determine whether the low plasma fibrinogen level in severe trauma correlates with decreased fxiii activity.

Eligibility criteria:
inclusion criteria: * a patient with presumed severe trauma admitted to the participating centre exclusion criteria: * inflammatory disease * malignant disease * pregnancy * receipt of any fibrinogen / coagulation factor xiii product before blood sampling * patients on dabigatran
foot perfusion by dynamic contrast enhanced mri in patients with peripheral artery disease

Conditions: Peripheral Arterial Disease; Perfusion

Summary: we investigate the peri-operative foot perfusion through dynamic contrast enhanced mri in patients with peripheral artery disease


Eligibility criteria:
inclusion criteria: * 18 to 80 years old; * pad patients with fontaine grade ii-iv or rutherford grade 2-6 and underwent a successful revascularization; * patients completed both pre- and post-operative mri workups; * patients signed the informed consent form and be able to complete the clinical follow-up for 1 months. exclusion criteria: * patients has participated in other clinical studies; * patients with heart failure (nyha iii/iv)/right to left shunt heart disease/ severe aortic and mitral insufficiency/acute coronary syndrome/malignant arrhythmia/severe pulmonary hypertension (pulmonary artery pressure at least 90 mmhg)/moderate to severe renal insufficiency (creatinine clearance rate\<60 ml/min) * any allergic constitution; * pregnancy and childbirth; * life expectancy\<12 months.
spinal fusion and rehabilitation study

Conditions: Spondylolisthesis, Degenerative; Spondylolisthesis, Isthmic

Summary: the aim of the present study is to analyse the significance of postoperative combined strength and aerobic training for outcome of the lumbar fusion patients compared to usual care (patients with isthmic or degenerative spondylolisthesis).

most of the studies published so far about lumbar fusion surgery have been interested in surgical procedure itself or in comparison of conservative or operative treatment. less information is available about long-term outcome and exercise programs for operated patients. therefore the investigators have developed "spine fusion register", which include data on surgery procedure and outcome (pain, disability, back muscle function, quality of life, working capacity, reoperations and complications etc.) before and after surgery up to 5 years (started in january 1st, 2008). the main purpose of the present study is to analyze the significance of 12-month strength and aerobic training for outcome of the lumbar fusion patients compared to usual care. patients (n=100) with lumbar fusion because of isthmic or degenerative olisthesis will be will be stratified by catchments area and randomized into combined strength and aerobic training group or into the control group.

Eligibility criteria:
inclusion criteria: * over 20 years old * isthmic or degenerative spondylolisthesis exclusion criteria: * cardiovascular or musculoskeletal diseases, which may exclude their ability to perform strength and endurance training and testing * metabolic bone disease * psychosocial instability * malignant disease

Keywords: spinal fusion pain disability muscle strength mobility quality of life lumbar isthmic or degenerative spondylolisthesis
study to evaluate long-term tolerability and safety of oral prucalopride in chronic constipation

Conditions: Chronic Constipation

Summary: objectives: evaluation of the clinical long-term safety, tolerability, patient satisfaction, pharmacokinetics and pattern of use of oral prucalopride tablets given in doses up to 4 mg once daily to patients with chronic constipation


Eligibility criteria:
inclusion criteria: 1. male or non-pregnant, non-breast-feeding female outpatients of at least 18 years of age 2. patient had completed the entire treatment period of the pru-int-6 study or the pru-int-12 study . exclusion criteria: 1. patients with impaired renal function 2. patients with clinically significant abnormalities of haematology, urinalysis, or blood chemistry. 3. females of child-bearing potential without adequate contraceptive protection during the study.
enhancing sleep quality for nursing home residents with dementia

Conditions: Alzheimer Disease; Dementia; Sleep Disorder; Sleep Disturbance

Summary: this was a pilot study (r61) to prepare for a full clinical trial (r33) aiming to improve clinical outcomes for an important, growing, and vulnerable population-nursing home (nh) residents with alzheimer's disease or related dementias (adrds). the goal was to pilot and refine the research methods and intervention that would be subsequently evaluated in a full implementation trial (hybrid type iii). the goal of the evidence-based intervention (lock) that was refined in this pilot study and will be evaluated in the subsequent full clinical trial is to improve the sleep of nh residents with adrd.

in community (non-va) nhs \[one from each of 3 national nh corporations\], the multi-disciplinary research team achieved two aims: (1) refined the lock program to focus on sleep for residents with adrd during this pilot (r61) phase, (2) which prepared the team for the second phase of this two-part nia-funded grant (the r33 phase) to test the impact and sustainability of this intervention for nh residents with adrd in an incomplete stepped-wedge randomized controlled trial. this pilot study r61 phase (1 year; n = 3 nhs; 1 nh per corporation) had the following specific aims: 1. refine the lock sleep program train-the-trainer protocol by implementing and pilot-testing in three nhs. 2. test and refine the research methods to: effectively identify eligible nhs and residents; obtain consent; collect primary data from residents and staff (sleep time via actigraph); explore staff impressions of additional sleep measurement devices (fitbits); transfer primary and secondary data to our data center; and merge all data.

Eligibility criteria:
inclusion criteria: * nursing home residents aged \>=50 years with an alzheimer disease or related dementia (adrd) diagnosis, identified by nursing home staff participating in frontline lock sleep huddles as having sleep problems exclusion criteria: * residents with a high risk of osa who are not being treated for osa because actigraph measurements are inaccurate in that population. * residents who have a persistent bilateral resting tremor or paralysis in both arms (a subset of persons with parkinson's disease and related significant tremor-causing diagnoses), due to actigraph measurement inaccuracies